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DIRECT (DIabetes REsearCh for patient straTification), a consortium funded by the Innovative Medicines Initiative (IMI), announced today the launch of a 45 million Euro project focusing on a stratification of patients with diabetes. Scientists and clinicians working in academia have joined forces with the pharmaceutical industry to tackle the current bottlenecks in diabetes drug development and to develop a personalized medicines approach to treatment of ‘type 2 diabetes’ (T2D) with either existing or novel therapies.

Leading European experts from 21 academic institutions and four pharmaceutical research organizations officially launched the DIRECT project on February 1st. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), a research institute related to the Hospital Clínic of Barcelona, is the only Spanish institution involved in this innovative project. The IDIBAPS team led by Dr. Jorge Ferrer, Genomic Programming of Beta Cells and Diabetes, will focus on systems biology component of this translational research in collaboration with teams from Oxford, Copenhagen and Geneva. Their challenge is to identify genomic and epigenomic changes of pancreatic cells to provide biomarkers for Type 2 diabetes.

The project is supported by the Innovative Medicines Initiative (IMI), a unique Public Private Partnership (PPP) between European Union and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations / EFPIA). The EU contributes to this PPP a total of one billion Euro over ten years, which is matched in-kind by the EFPIA member companies.

Type 2 diabetes is a pandemic disease which currently affects 285 million people worldwide and which is anticipated to affect 439 million people worldwide by 2030. Whilst Type 2 diabetes is usually assumed to be one condition, the DIRECT consortium believes that it can be stratified into different subtypes that may progress differently or be treated differently to other subtypes. The aim of the consortium is the discovery, development and application of biomarkers, or tests, that predict who gets diabetes, whose diabetes deteriorates rapidly after diagnosis and who responds well or poorly to diabetes therapy. This will result in the development of new drugs and the better targeting of existing drugs in order to improve outcomes of patients with diabetes.

DIRECT is a unique collaboration of leading European academic groups and pharmaceutical companies in the diabetes field in Europe. Around 150 researchers operating in nine different scientific work packages will collect phenotypic and genomic data from pre-diabetic and diabetic patients, diabetic patients treated with anti-diabetic drugs and by bariatric surgery. More than 100.000 samples of well-characterized T2D patients will be provided by the consortium partners to apply novel methods in systems biology and pathway analysis with the goal of identifying biomarkers that predict the incidence of diabetes, the rapid deterioration of glycaemia or the response/non-response to therapy. The identified biomarker candidates will then be validated in prospective clinical trials for later use as new diagnostics or prognostics as well as in the development of novel therapeutics.

“It has been fascinating to see how quickly a strong consortium has been formed, building bridges between the very different worlds of academic and the pharmaceutical industry research organizations,“ said Hartmut Ruetten from Sanofi. Ewan Pearson from University of Dundee and Veikko Koivisto from Eli Lilly, the coordinators of DIRECT, agree: “There is no doubt that strong collaboration between diabetes clinicians and scientists in academia, and the experts in biomarker and drug discovery, and drug trials, in the pharmaceutical industry will result in improvements in patient care, and that’s what DIRECT is all about – better, personalized treatment for patients with diabetes.”

About DIRECT:

The DIRECT team, coordinated by Sanofi, Eli Lilly and the University of Dundee is working on the identification and validation of biomarkers to improve treatment of Type 2 Diabetes with either existing or novel therapies.

The seven year scientific program will deliver:

Prospective studies, and large scale retrospective data analysis, to define and intensively study groups of people with different rates of deterioration of glycaemia (both pre-diabetes and with diabetes) and different response to diabetes therapies

A high quality European database to store relevant genomic and phenotypic data sets.

Application and development of novel data mining tools and algorithms to generate stratification and response biomarker candidates (i) describing patients at risk of diabetes and at risk for disease progression, (ii) to derive a personalized treatment strategy and (iii) potentially identify new drug development targets.

Development of biomarker assays: “Industrialized” confirmation and qualification of new or already known biomarkers for personalized therapy in well defined sub-populations.

About IMI: The Innovative Medicines Initiative is a unique Public Private Partnership (PPP) between the pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Union represented by the European Commission. IMI’s overall goal is to make Europe again the world leader in pharmaceutical research for the benefit of the economy and society, by removing research bottlenecks in the current drug development process.